MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,foreign report with the FDA on 2019-05-03 for COREGA TABS BIO FORMULA manufactured by Block Drug Co., Inc..
[144124815]
Argus case id (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[144124816]
Furry feeling in mouth [oral discomfort], swallowed product [accidental device ingestion]. Case description: this case was reported by a consumer via call center representative and described the occurrence of oral discomfort in a (b)(6)-year-old male patient who received denture cleanser (corega tabs bio formula) tablet for product used for unknown indication. On an unknown date, the patient started corega tabs bio formula. In 2019, an unknown time after starting corega tabs bio formula, the patient experienced oral discomfort and accidental device ingestion (serious criteria gsk medically significant). The action taken with corega tabs bio formula was unknown. On an unknown date, the outcome of the oral discomfort was not reported and the outcome of the accidental device ingestion was unknown. It was unknown if the reporter considered the oral discomfort and accidental device ingestion to be related to corega tabs bio formula. Additional details: the consumer accidentally took some small sips of corega tabs bio formula. At time of reporting he experienced furry feeling in mouth.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1020379-2019-00024 |
| MDR Report Key | 8579059 |
| Report Source | CONSUMER,FOREIGN |
| Date Received | 2019-05-03 |
| Date of Report | 2019-04-16 |
| Date Mfgr Received | 2019-04-16 |
| Date Added to Maude | 2019-05-03 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Street | PO BOX 13398 |
| Manufacturer City | RESEARCH TRIANGLE PARK NC 27709 |
| Manufacturer Country | US |
| Manufacturer Postal | 27709 |
| Manufacturer Phone | 8888255249 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COREGA TABS BIO FORMULA |
| Generic Name | DENTURE CLEANSER |
| Product Code | EFT |
| Date Received | 2019-05-03 |
| Operator | LAY USER/PATIENT |
| Device Availability | * |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BLOCK DRUG CO., INC. |
| Manufacturer Address | MEMPHIS TN US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-05-03 |